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A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients

Phase 4
21 Years
Not Enrolling
Cancer, Spinal Fractures

Thank you

Trial Information

A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients


1.1. Objectives

The primary objective of this study is to evaluate the safety and effectiveness of balloon
kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy
in patients with cancer.

1.2. Primary Endpoint

The primary endpoint of the study is the improvement in functional status, as measured by
the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the
study is that the mean improvement will be larger in subjects initially assigned to
management with balloon kyphoplasty. Note that all subjects will undergo 12 months of
follow-up after initial treatment assignment.

1.3. Secondary Endpoints

The following secondary endpoints will also be examined. Comparisons will be made at each
follow-up visit.


- Rate of study treatment-related adverse events

- Change in neurological status


- Change in functional status as assessed with

- the Roland-Morris Disability Questionnaire

- the Karnofsky Performance Scale

- Change in quality of life as assessed by the SF-36v2™ Health Survey

- Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS)

- Change in back-pain analgesics used

- Change in ambulation status

- Changes in activities of daily living

- Time to treatment failure


- Change in spinal deformity, defined as the degree of spine angulation as assessed by an
independent radiologist at the core laboratory

- Rate of subsequent vertebral body fractures, as assessed by independent radiologists at
the core lab

In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in
an improvement in clinical or radiographic outcomes compared to baseline and compared to
non-surgical treatment, with a preservation of outcomes in long-term follow-up.

Inclusion Criteria:

1. One to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s),
T5-L5, with either bone marrow edema imaged by magnetic resonance imaging (MRI) or a
fracture imaged by plain radiographs using the method of Genant

2. Pain NRS score ≥4 on a scale of 0 to 10

- When the patient is newly diagnosed with multiple myeloma, the pain assessment
must not be done until after completion of at least one pulse of steroid therapy
or one week after the initiation of active multiple myeloma therapy.

3. Roland Morris Disability Questionnaire score ≥ 10 on a scale of 0 to 24

4. Patients must be at least 21 years old.

5. No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to

6. No change in chemotherapy regimen (change in dose(s) permitted) planned for at least
1 month following enrollment

7. No major surgery to the spine planned for at least 1 month following enrollment

8. Life expectancy of ≥ 3 months

9. Patient has sufficient mental capacity to comply with the protocol requirements

10. Patient has stated availability for all study visits

11. Patient is able to understand the risks and benefits of participating in the study
and is willing to provide written informed consent.

Exclusion Criteria:

1. Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary
plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites
other than the index VCF are eligible.

2. Concurrent Phase I investigational anti-cancer treatment

3. Significant clinical morbidities (aside from the index fracture(s) and cancer) that
may potentially interfere with the collection of data concerning pain and function

4. VCF morphology deemed unsuitable for balloon kyphoplasty

5. Additional non-kyphoplasty surgical treatment is required for the index fracture

6. Patients requiring the use of high-dose steroid (≥ 100 mg prednisone or 20 mg
dexamethasone per day), intravenous (IV) pain medication, or nerve block to control
chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids
for treatment of their cancer (for at least 30 days) are eligible.

7. Patients with a platelet count of < 20,000 measured at the time of hospital admission
for the procedure

8. Spinal cord compression or canal compromise requiring decompression

9. Patients with osteoblastic tumors at the site of index VCF. Patients with
osteoblastic tumors outside of vertebral levels intended for kyphoplasty may be

10. Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in
the presence of active or incompletely treated local infection)

11. Known allergy to bone cement or contrast medium used in the treatment of study

12. MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted
biostimulators, cochlear implants, penile prosthesis)

13. Positive baseline pregnancy test (for women of child-bearing potential)

14. Patients who may require allogeneic bone marrow transplantation during the course of
the study.

Other Reasons for Lack of Enrollment:

A. Patient is afraid to have surgery

B. Patient is afraid to have anesthesia

C. Patient/family is not willing to participate in research

D. Patient is not willing to be randomized

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month

Outcome Description:

The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability)

Outcome Time Frame:

Baseline and 1 Month

Safety Issue:


Principal Investigator

James Berenson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute for Myeloma & Bone Cancer Research


United States: Institutional Review Board

Study ID:

SP0401 - CAFE Study



Start Date:

May 2005

Completion Date:

December 2009

Related Keywords:

  • Cancer
  • Spinal Fractures
  • Balloon Kyphoplasty
  • Cancer
  • Vertebral Compression Fracture
  • Back Pain
  • Spine
  • Fractures, Bone
  • Spinal Fractures
  • Fractures, Compression



University of UtahSalt Lake City, Utah  
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Cleveland ClinicCleveland, Ohio  44195
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
Karmanos Cancer CenterDetroit, Michigan  48201
Valley Radiology Inc., UCSDEscondido, California  92025
Boulder Neurosurgical AssociatesBoulder, Colorado  80304
Sibley Memorial HospitalChevy Chase, Maryland  20815
Greater Oncology AssociatesSilver Spring, Maryland  20910